Jobs in Germany
Ihre Aufgaben
As a Senior Regulatory Affairs Specialist, you will work closely with all departments and be mainly responsible to prepare / review and maintain the technical documentation according MDR 2017/745 (EU) and preparation, review and maintenance as well as submissions for international approval.
- Responsible for the creation, review and maintenance of technical documentation
- Responsible for preparation, review and maintenance as well as supporting of submissions for international approval, for re-registration activities and for the internal communication in view of international regulatory related changes
- Support and guidance of other department for Medical Software and Cybersecurity
- Support Clinical Evaluation, Vigilance / Post-Marketing Surveillance activities
- Contribution to risk assessments
- Support in the creation and handling of Manufacturer Information (IFU, Labels, Brochure, Website, UDI)
- Support during audit (internal, external, MDSAP, etc.)
- Standard evaluation and administration in the area of expertise
- Support database entries (EUDAMED, DMIDS, GUDID, etc.)
Ihr Profil
- Appropriate Science or Engineering Degree, preferably in medical technology, or equivalent combination of education and experience in the field of technical documentation and manufacturer information
- At least 5 years of working experience with active / non-active medical devices (sterile / non-sterile)
- Fundamental understanding of the new European Medical Device Regulation (MDR 2017/745 (EU))
- Fundamental understanding of ISO medical device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601-1, IEC 62304, FDA 89 FR 7523, Cybersecurity, etc.)
- Knowledge of regulatory affairs affecting processes (e.g. product
- development, risk management, project management, Vigilance, PMS, CAPA, Complaints, etc.)
- Ability to work under pressure and assertiveness
- Strong team player who is willing to take on and support other activities outside core expertise as required
- Ability to work flexibly across a multi-disciplinary team in jointly achieving given goals
- Able to manage multiple tasks and perform with accuracy and a high attention to detail
- Excellent verbal and written communicator; clear and concise in communications with internal and external partners
- English (C1) and German (B1) language skills, written and spoken
- Time management and organizational skills
- Consistent, quality work and follows through on commitments.
- Basic computer skills (MS Office / MS Visio)
Warum wir?
- Personal induction plan and comprehensive onboarding
- Flexible working hours
- 30 days of holiday
- interesting tasks in a dynamic, international environment
- Continuous training and development
- Flat hierarchies
- Attractive canteen
- Free coffee, tea and water
- Employee events
- Charging stations for electric cars
- Accident insurance
- Employer contribution to VWL
- Employee fund with various allowances and subsidies
- Free language courses
Helpful information
- Read what is m/w/d in the job title
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